all nite
- Product NDC
- 0904-6465
- 11-digit product format
- 009046465
- Labeler code
- 0904
- Product ID
- 0904-6465_9bfd7bea-ca99-41ae-a92f-4c91ac3327f3
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Dextromethorphan HBr, Doxylamine succinate
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2012-11-19
- Substance
- ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
- Active strength
- 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL
- Pharmacologic classes
- Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- all nite
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 650 mg/30mL |
| DEXTROMETHORPHAN HYDROBROMIDE | 30 mg/30mL |
| DOXYLAMINE SUCCINATE | 12.5 mg/30mL |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| bf324df6-7127-7deb-def5-2681c136cd03 | Product name | 3 | 20250325 |
| 59361619-24d9-b610-eca6-5a7f25ed5e03 | Product name | 5 | 20240909 |
| 43a1ed49-eae2-4840-8075-cb4b33478540 | Product name | 1 | 20230425 |
| ba088a92-ab5e-b2d4-e908-f5ea691b7587 | Product name | 7 | 20210201 |
| f4368033-af8c-41bf-a84b-ff77392b8522 | Product name | 1 | 20161229 |
| 76633df9-0d59-4b88-03ed-21dee1b966f8 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0904-6465-09 | all nite | 237 mL in 1 BOTTLE | SOLUTION | 237 | 5 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0904-6465-09 | ML - Milliliter | 0904-6465 | 0311bb96-dabb-460d-b725-f5d4a1248301 | 1 | 2016-07-19 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Foster and Thrive Cherry Cough Drops | MENTHOL | McKesson | 49eefa70-cef9-d7ec-e063-6294a90ac321 | 2026-02-03 | Warnings | M012 |
| Foster and Thrive Honey Lemon Cough Drops | MENTHOL | McKesson | 49f13ee3-6bb3-e500-e063-6394a90a152d | 2026-02-03 | Warnings | M012 |
| Daytime Cold and Flu Mini Softgels | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Shield Pharmaceuticals Corp | 63cb19d4-2306-4723-a95e-9d2d8b9eccd0 | 2026-02-03 | Warnings | M012 |
| Foster and Thrive SF Honey Lemon Cough Drops | MENTHOL | McKesson | 49f41c30-f806-44ba-e063-6394a90a5a67 | 2026-02-03 | Warnings | M012 |
| Nighttime Cold and Flu Mini Softgels | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Shield Pharmaceuticals Corp | b9af8ab4-a7cb-4adf-9f6f-398c6bb7f853 | 2026-02-03 | Warnings | M012 |
| allergy relief | DIPHENHYDRAMINE HCL | Meijer Distribution Inc | 7c2fc244-bfc5-4e3c-aa90-8bc3d067b64f | 2026-02-03 | Warnings | M012 |
| Cold and Allergy D | PSEUDOEPHEDRINE HCL, TRIPROLIDINE HCL | Walgreen Company | 832ac849-7f4a-489a-a704-9d4388a75a71 | 2026-02-03 | Warnings | M012 |
| severe cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | HyVee Inc | 987f908b-7af7-4705-bfb4-c48d771c380d | 2026-02-03 | Warnings | M012 |
| tussin dm nighttime max | DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | HyVee Inc | 1f3fb451-84c9-432e-ac67-2694dd66c815 | 2026-02-03 | Warnings | M012 |
| Robafen DM Cough | DEXTROMETHORPHAN HBR, GUAIFENESIN | Major Pharmaceuticals | 7c9660b7-cb00-449b-b65f-aa42d8ce1942 | 2026-02-03 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL | Walgreen Company | 6b0d261f-fc27-4b34-88b1-cd3d72766760 | 2026-02-02 | Warnings | M012 |
| Tussin DM | DEXTROMETHORPHAN HBR, GUAIFENESIN | Cardinal Health 110, LLC. DBA Leader | ebfcb699-3369-4697-9841-44015b1c9808 | 2026-02-02 | Warnings | M012 |
| Cherry Sore Throat Lozenges | BENZOCAINE, MENTHOL | Meijer Distribution Inc. | 2f6de590-7cad-25d7-e054-00144ff8d46c | 2026-02-02 | Warnings | M012 |
| Mixed Berry Sore Throat and Cough lozenge | DEXTROMETHORPHAN HYDROBROMIDE | Meijer Distribution, Inc. | 304ff4db-201a-60a4-e054-00144ff8d46c | 2026-02-02 | Warnings | M012 |
| Allergy Relief Plus Congestion | DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL | Walgreen Company | 38d91107-d95c-40f2-a27e-561f951e519d | 2026-02-02 | Warnings | M012 |
| Tussin Severe | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | HyVee Inc | 85252999-3463-45fe-b4a9-7a97960b41b1 | 2026-02-02 | Warnings | M012 |
| Amazon Basics Cherry Cough Drops 30ct | MENTHOL | Amazon | 3e74e209-c9c9-3979-e063-6294a90afcfa | 2026-02-01 | Warnings | M012 |
| Amazon Basics Honey Lemon Cough Drops 30ct | MENTHOL | Amazon | 3e75838b-e1c9-2d42-e063-6294a90aab82 | 2026-02-01 | Warnings | M012 |
| cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | HyVee Inc | 5110526f-51fd-401e-ba52-520674d34f37 | 2026-02-01 | Warnings | M012 |
| Chest Rub | CAMPHOR, EUCALYPTUS OIL, MENTHOL | Amazon.com Service LLC | 673996ab-6e57-4feb-8af3-d8b474741a8d | 2026-01-30 | Warnings, Adverse reactions | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1043400 | acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 30 mL Oral Solution | PSN | 945a4068-3630-4f1d-b794-d2f1603af285 | 5 |
| 1043400 | acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution | SCD | 945a4068-3630-4f1d-b794-d2f1603af285 | 5 |
| 1043400 | acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral Solution | SY | 945a4068-3630-4f1d-b794-d2f1603af285 | 5 |
| 1043400 | acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral Solution | SY | 945a4068-3630-4f1d-b794-d2f1603af285 | 5 |
| 1043400 | APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution | SY | 945a4068-3630-4f1d-b794-d2f1603af285 | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0904-6465-09 | 00904646509 | 237 mL in 1 BOTTLE (0904-6465-09) | 237 ml | 2012-11-19 | 0000-00-00 | No | No | Current |